Device recall

Z-2014-2008: Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System…

FDA device recall · Class II · Philips Medical Systems

Key facts

Recall number (Z-number) Z-2014-2008
Recall event 48163
Product Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.
Product code IYN
Recalling firm Philips Medical Systems
Recall class Class II
Status Terminated
Termination date Aug 18, 2011
510(k) numbers K031552
FEI number 1218950

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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